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Rozerem

Last reviewed on RxList: 10/18/2016
Rozerem Side Effects Center

Last reviewed on RxList 10/25/2016

Rozerem (ramelteon) is a hypnotic type sedative used to treat insomnia that is associated with having trouble falling asleep. Unlike some other sleep medications, Rozerem is not known to be habit-forming. Common side effects of Rozerem include:

  • dizziness,
  • tiredness,
  • daytime drowsiness,
  • nausea, or
  • worsening sleep problems.

Tell your doctor if you have unlikely but serious side effects of Rozerem including:

  • decreased sexual desire,
  • missed menstrual periods,
  • nipple discharge, or
  • difficulty becoming pregnant.

The recommended dose of Rozerem is 8 mg taken within 30 minutes of going to bed. Rozerem may interact with primaquine, thabendazole, rifampin, antibiotics, heart rhythm medications, or antifungal medications. Tell your doctor all medications you are taking. Rozerem should be used only when prescribed during pregnancy. It is unknown if this drug passes into breast milk and the effect on a nursing infant is unknown. Consult your doctor before breastfeeding.

Our Rozerem (ramelteon) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Rozerem Consumer Information

Some people using this medicine have engaged in activity such as driving, eating, or making phone calls and later having no memory of the activity. If this happens to you, stop taking ramelteon and talk with your doctor about another treatment for your sleep disorder.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking ramelteon and call your doctor at once if you have a serious side effect such as:

  • unusual thoughts or behavior, hallucinations, worsening depression, thoughts about hurting yourself;
  • a missed menstrual period;
  • nipple discharge; or
  • loss of interest in sex.

Less serious side effects may include:

  • drowsiness, tired feeling;
  • dizziness;
  • nausea; or
  • worsening sleep problems.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Rozerem (Ramelteon)

Rozerem Professional Information

SIDE EFFECTS

The following serious adverse reactions are discussed in greater detail in other sections:

  • Severe anaphylactic and anaphylactoid reactions [see WARNINGS AND PRECAUTIONS]
  • Abnormal thinking, behavior changes, and complex behaviors [see WARNINGS AND PRECAUTIONS]
  • CNS effects [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Adverse Reactions Resulting in Discontinuation of Treatment

The data described in this section reflect exposure to ROZEREM (ramelteon) in 5373 subjects, including 722 exposed for 6 months or longer, and 448 subjects for one year.

Six percent of the 5373 individual subjects exposed to ROZEREM (ramelteon) in clinical studies discontinued treatment owing to an adverse event, compared with 2% of the 2279 subjects receiving placebo. The most frequent adverse events leading to discontinuation in subjects receiving ROZEREM (ramelteon) were somnolence, dizziness, nausea, fatigue, headache, and insomnia; all of which occurred in 1% of the patients or less.

ROZEREM (ramelteon) Most Commonly Observed Adverse Events

Table 1 displays the incidence of adverse events reported by the 2861 patients with chronic insomnia who participated in placebo-controlled trials of ROZEREM (ramelteon) .

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in clinical trials of other drugs, and may not reflect the rates observed in practice. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates.

Table 1: Incidence (% of subjects) of Treatment-Emergent Adverse Events

MedDRA Preferred Term Placebo
(n=1456)
Ramelteon 8 mg
(n=1405)
Somnolence 2% 3%
Fatigue 2% 3%
Dizziness 3% 4%
Nausea 2% 3%
Insomnia exacerbated 2% 3%

Read the entire FDA prescribing information for Rozerem (Ramelteon)

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